COLUMBIA, Md., Sep 16, 2009 (BUSINESS WIRE) -- Celsion Corporation (NASDAQ:CLSN) announced today the Company's DIGNITY clinical trial evaluating the use of ThermoDox(R) in combination with hyperthermia for the treatment of Recurrent Chest Wall (RCW) Breast Cancer was aired during commercial breaks on Good Morning America and CBS Sunday Morning this past weekend. The media clip, featuring Dr. Brigid M. O'Connor, Principal Investigator and Radiation Oncologist at Rhode Island Hospital, provides an overview of RCW Breast Cancer and the DIGNITY trial, which evaluates ThermoDox's potential to treat chest tumors and provide a quality of life benefit for those dealing with the disease. The informational segment ran in the Chicago, San Francisco, Los Angeles and Providence, R.I. markets on September 12th and 13th and will also appear this upcoming weekend in Los Angeles and in October in New York City during National Breast Cancer Awareness Month. A replay of the feature is posted on the Celsion website. The Company invites patients, their families, and healthcare providers to view it by selecting "Recurrent Breast Cancer Clinical Trial Video" at: www.celsion.com
Recognizing the importance of the DIGNITY Breast Cancer trial and its potential to provide a treatment of significance, Celsion has undertaken an innovative, integrated media outreach campaign. The initiatives include on-line outreach, dissemination of clinical articles and other printed material and placing TV features. The program is designed to reach a broad constituency including breast cancer patients, breast cancer support groups, oncologists and other physicians.
About the DIGNITY Clinical Trial
The DIGNITY clinical trial is a Phase I/II open label, dose escalating trial to evaluate the safety and efficacy of ThermoDox with hyperthermia for the treatment of Recurrent Chest Wall (RCW) Breast Cancer, an aggressive form of cancer with a poor prognosis and limited treatment options. The primary endpoint in the DIGNITY trial is durable complete local response at the tumor site. Celsion intends to enroll 100 patients in the United States within the calendar year 2010. The results from the DIGNITY trial are expected to build on the promising data from the Phase I dose escalation study currently being conducted at Duke University Medical Center.
About Recurrent Chest Wall Breast Cancer
Depending on risk factors, up to 40% of women with mastectomies may experience breast cancer recurrence at the chest wall. The disease is a highly aggressive form of cancer and is generally defined as the recurrence of tumor to the area of the initial definitive treatment such as mastectomy. There are a significant number of women diagnosed with breast cancer recurrence at the chest wall that have exhausted all treatment options and cannot be treated with further surgical resection, radiation, or existing chemotherapy.
ThermoDox(R) is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. ThermoDox(R) is administered intravenously and in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox has also demonstrated evidence of efficacy in a Phase I study for primary liver cancer. Celsion has been granted FDA Orphan Drug designation for ThermoDox and is conducting a pivotal 600 patient global Phase III study in primary liver cancer under a FDA Special Protocol Assessment.
Additional information on ThermoDox(R) clinical studies for RCW breast cancer and primary liver cancer can be found at: www.clinicaltrials.gov
ThermoDox(R) is a registered trademark of Celsion Corporation
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: http://www.celsion.com
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
SOURCE: Celsion Corporation
Sean Moran, 410-290-5390 (Investors)
Senior Vice President and Chief Financial Officer
The Trout Group
Marcy Nanus, 646-378-2927 (Investors)
Copyright Business Wire 2009